Like any business, a successful cannabis operation involves multiple processes involving materials, equipment, and personnel. Adherence to Good Manufacturing Practices (GMP), a globally recognized set of proactive good practices, ensures that your operation is maintained in a way that mitigates risks: risks of product failure, reprocessing, withdrawals, and more .
The data collected throughout your processes provides management with evidence that established processes and GMPs are being met.
Data can also be trending and correlated to identify inefficiencies, serve as early warning signs of equipment aging, and more.
But first, it is crucial to start by understanding the 10 GMP principles that apply regardless of the type of cannabis. operation You have.
Document them as part of your overall quality system and you will have a meaningful way to mitigate your operational risks and find opportunities for improvement, improving both your top results and your results.
So what are they?
Principle 1 – Writing Procedures
Standard Operating Procedures (SOPs) are self-contained step-by-step instructions that allow workers to perform routine operations consistently, and documented training on PCOS confirms the employee’s understanding of their work tasks.
Well-written SOPs ensure a controlled and consistent work and performance of employees in an organization, at all levels.
The SOPs coordinate actions and communication in all shifts and between departments and different facilities.
Unfortunately, it’s too easy to type SOP once and let it collect dust in a folder, out of sight and out of mind.
These procedures should be easy to follow and practical: a trusted resource that is your first line employees it can always be toured during the day.
Principle 2 – Follow written procedures
Have you taken the time to write good procedures, but are they still being followed?
Whether you call them Work Instructions, Standard Operating Procedures (SOPs), or something similar, they should be easy for your computer to understand.
Operators write the best SOPs for operators and review them frequently to ensure that changes are reflected in the process.
Following procedures avoids product barriers, minimizes errors, and ensures the manufacture of consistent, high-quality products.
You are now on your way to complying with GMP regulations!
Principle 3 – Document the work correctly
Documentation of tasks and data must be done quickly and accurately.
Procedures must be in place to ensure that documentation is accurate, legible, original and real-time.
Any raw data generated that can be used to make quality decisions must be retained.
Without written evidence, there is no way to show that procedures have been properly followed making investigations when something goes wrong difficult if not impossible.
In addition, this documentation can be trending and used to identify opportunities for improvement.
Principle 4 – Facilities and equipment
Appropriate design, the construction and location of a facility must be planned from the beginning.
The use of Quality by Design (QbD) principles minimizes product quality risk and maximizes efficiency, capacity, and manufacturing output.
Have you considered design and product / process / staff when designing your process? Even though you’re already up and running, it’s not too late.
Check your facilities and equipment for hazards: Improperly designed operations create opportunities for microbial and particulate contamination, as well as cross-contamination of the product.
There must be controls for air and water quality, ventilation, lighting, temperature and humidity to prevent any negative impact of the product.
Equipment must be qualified, key components calibrated and properly maintained and repaired in a timely manner.
Having the most common replacement parts on hand and establishing a preventive maintenance program is a key component.
Most equipment failures can be attributed to a lack of preventive maintenance. Murphy’s Law always shuts down your computer at the worst possible time.
Principle 5 – Process validation
The purpose of validation is to ensure that the equipment and processes operate in a consistent manner as intended.
How else do you know that all the equipment, materials and ingredients and trained staff have a reliable process that gives you a consistent product over time?
Consistent performance is critical to maintaining the security and effectiveness of a product and enhancing an organization’s reputation for quality and reliability.
Simply put, validation demonstrates control over critical operations.
Validation includes the establishment of ongoing control and verification procedures that allow troubleshooting and a process to resolve issues when they arise.
For example, your preventive maintenance (PM) and calibration programs provide a critical mechanism for maintaining process control, production consistency, and efficiency.
Principle 6 – Demonstrate job competence
An appropriate combination of education, training, and experience enables your staff to perform their assigned functions.
Training is a basic GMP practice. Defined job descriptions, roles, and responsibilities ensure that your operation is properly staffed.
Getting started with an organization chart allows top management to ensure that the right skills are recruited as your business grows.
Establishing the appropriate training and competency requirements for all employees is critical.
Principle 7 – Good record keeping
Accurate and organized records provide a way to keep track of activities from the receipt of raw materials to the release of the final product.
Records must be kept for the receipt and inspection of components, containers, enclosures and labels.
You are already properly documenting your work (Principle 3), having an organized system to maintain these records guarantees that you will be able to review them when necessary.
As the saying goes, “If it wasn’t documented, it didn’t happen!”
Principle 8 – Control pollution
Pollution is the presence of any unwanted substance in a system or product.
Pollution comes in three (3) ways: microbial, Cross-contamination of particles and products.
It is all too easy for mistakes to lead to contamination: from a poorly placed raw material, a poorly labeled or mislabeled bottle, to poor sanitation and hygiene practices that lead to microbial buildup, not controlling pollution can be incredibly costly for an organization.
Make sure you have documented processes and procedures in place to control and mitigate the risk of contamination in your operation.
Principle 9 – Quality control
Quality control is much more than the final test of the process or product, known as quality control (QC).
You also need Quality Assurance (QA)! Quality control is the process of quality management to minimize risk.
This includes ensuring that all products, from raw materials to final release, meet established standards and specifications and are safe and effective.
Quality must be incorporated into every step of the product life cycle.
The result? Quality control serves as a way to verify that all of your quality assurance processes and steps are doing their job by providing consistent, high-quality products.
And when the end result of a test is questionable or does not meet the specifications, you have the data to review and identify the root cause.
Principle 10 – Compliance Audit
Internal audit programs allow organizations to conduct self-assessments of the health of their quality management system (QMS) and overall performance.
Self-assessments assess compliance and identify gaps.
Establishing an internal audit program provides a proactive approach to identifying and resolving issues.
Documentation of internal audit activities provides objective evidence that an organization is conducting due diligence on compliance with both internal and external standards and requirements.
The last principle: the compliance audit is your answer to “Am I satisfied?”.
Whether it’s the laws of your state or the 10 principles of GMP, having an audit program is critical to the health of your business.
The best audit programs involve staff with new eyes in an operational area.
Their lack of daily familiarity with the process allows them to ask questions that operators take for granted and can be very valuable in identifying both the risks of non-compliance as well as opportunities for improvement!